BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARLY BIRD BLEED MONITORING SYSTEM

    MDR report key: 16173395 · Received January 16, 2023

    Report

    Report Number
    3016011241-2022-00001
    Event Type
    Injury
    Date Received
    January 16, 2023
    Date of Event
    October 4, 2022
    Report Date
    October 31, 2022
    Manufacturer
    SARANAS, INC.
    Product Code
    QFJ
    UDI-DI
    00866532000419
    PMA / PMN Number
    DEN180021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE SARANAS ENGINEERING INVESTIGATION, THE EXPORTED EARLY BIRD DATA LOG REVEALED THAT THE FASTEST RATE AT WHICH THE PATIENT'S BIOIMPEDANCE REDUCED WAS -2.0 MILLIOHM/S, A RATE LOWER THAN THE EARLY BIRD FIRMWARE V5.0.5.0 DETECTION THRESHOLD OF -2.5 MILLIOHM/S. THERE WAS A DELAY IN SUBMITTING THIS MDR DUE TO DIFFICULTIES WITH THE ESG GATEWAY; REFER TO FDA ESG HELP DESK TICKETS 338559 AND 340672.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON (B)(6) 2022 AT (B)(6). THE COMPLAINT WAS RECEIVED ON OCTOBER 6, 2022 BY THE SARANAS SALES REPRESENTATIVE WHO WAS NOT PRESENT AT THE CASE. THE FACILITY REPORTING PERSON INDICATED THAT PRIOR TO THE PROCEDURE, THE SARANAS EARLY BIRD BLEED MONITORING SYSTEM (8FR) WAS PREPARED AT THE SCRUB TABLE PER THE INSTRUCTIONS FOR USE (IFU). THE EARLY BIRD BATTERY ISOLATION PULL TAB WAS REMOVED TO ACTIVATE THE DEVICE, AND A GREEN BLINKING LIGHT WAS OBSERVED ON THE DEVICE USER INTERFACE DISPLAY INDICATING THAT THE DEVICE WAS FUNCTIONING PROPERLY. THE DEVICE WAS TURNED OFF AND SUBSEQUENTLY IMPLANTED INTO THE PATIENT AS PER THE IFU. THE EARLY BIRD DEVICE WAS NOT TO BE ACTIVATED FOR BLEED MONITORING UNTIL AFTER THE MEDICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DURING THE TAVR PROCEDURE, INTERNAL BLEEDING EVENTS OCCURRED. IT WAS REPORTED THAT A BLEED HAD OCCURRED DUE TO A FAILED MANTA VASCULAR CLOSURE DEVICE IN THE COMMON LEFT FEMORAL ARTERY. ONE OF THE DOCTORS ALSO REPORTED THAT THERE MAY HAVE BEEN SOME BLEEDING FROM THE EPIGASTRIC ARTERY. AS SUCH, THE PHYSICIANS PERFORMED A BALLOON TAMPONADE OF THE LEFT FEMORAL ARTERY AND HELD PRESSURE TO HELP CONTROL THE BLEEDING WHILE THE PATIENT WAS IN THE CATHETERIZATION LAB. AFTERWARDS, THE PHYSICIAN'S FELT THAT THEY COULD SEND THE PATIENT TO THE FLOOR. AS SUCH, THE EARLY BIRD DEVICE WAS ACTIVATED, AND THE PATIENT WAS TRANSPORTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT. WHILE IN THE CVICU, THE PATIENT DEVELOPED A HEMATOMA, BECAME HYPOTENSIVE AND WAS TRANSPORTED BACK TO THE CATH LAB FOR SURGICAL INTERVENTION. THE BLEEDING WAS CONTROLLED, AND THE PATIENT HAS SINCE RECOVERED. IT WAS REPORTED THAT THE EARLY BIRD DID NOT TRIGGER ANY BLEED LEVELS. HOWEVER, THE INTERVENTIONALISTS FELT THAT THE DEVICE SHOULD'VE TRIGGERED A LEVEL 3 BLEED. SECTION 6, WARNINGS, IN THE SARANAS EARLY BIRD INSTRUCTIONS FOR USE STATES THAT, "THE EARLY BIRD MAY NOT DETECT AN INTERNAL BLEEDING COMPLICATION IF INTERNAL BLEEDING HAS ALREADY OCCURRED PRIOR TO INSERTION OF THE INTRODUCER SHEATH OR PRIOR TO INITIAL BIOIMPEDANCE MEASUREMENT." SECTION 13, FUNCTIONALITY, IN THE IFU STATES THAT, "THE EARLY BIRD PROVIDES EARLY DETECTION OF POTENTIAL INTERNAL BLEEDING COMPLICATIONS AND MONITORS FOR INTERNAL BLEEDING PROGRESSION BASED ON BASELINE BIOIMPEDANCE MEASUREMENTS AND BIOIMPEDANCE CHANGES THROUGHOUT THE COURSE OF A PROCEDURE." BECAUSE THE PATIENT HAD EXPERIENCED SIGNIFICANT BLEEDING IN THE LEFT COMMON FEMORAL ARTERY THE TISSUE AROUND THE BLEED DETECTION ARRAY OF THE EARLY BIRD DEVICE HAD BECOME SATURATED. AS SUCH, ONCE THE EARLY BIRD DEVICE WAS POWERED ON THE PATIENT'S BIOIMPEDANCE BASELINE MEASUREMENT (BLEED RATE THRESHOLD) WAS IMPACTED SUCH THAT THE DECREASE IN CHANGE OF THE BIOIMPEDANCE VALUE WAS NOT FAST ENOUGH TO TRIGGER THE EARLY BIRD DEVICE ALGORITHM. THE EARLY BIRD DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE WAS SUBJECTED TO VISUAL AND ELECTRICAL TESTING AND NO ANOMALIES WERE OBSERVED. THE DEVICE WAS ALSO SUBJECTED TO IMPEDANCE STABILITY TESTING AND MET TEST SPECIFICATIONS. IT IS CONCLUDED THAT THE EARLY BIRD DEVICE DID NOT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134043 EARLY BIRD BLEED MONITORING SYSTEM INTRAVASCULAR BLEED MONITOR QFJ SARANAS, INC. FG001-02 102610 00866532000419

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H MANTA VASCULAR CLOSURE DEVICE